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Senior Manufacturing Process Specialist

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization • Monitoring and reporting of process performance using statistical process control • Generation of data and reports to support Annual Product Reviews and Regulatory submissions • Troubleshooting of DCS (e.g Delta V) and PLC control systems • Investigating and resolving Deviations raised within the Manufacturing Department • Participate in/ Lead Cross Functional teams when required • Support of Commissioning and Qualification activities • Preparation and updating of Batch Records, Procedures and Work Instructions • Provide process and equipment related training as required within the Manufacturing Department • Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements. • Completion of all documentation in compliance with site procedures and GDP. • Lead, support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also support to validation activities. • Generate and assist with generation, review and revision of Manufacturing documentation as necessary. • Support ongoing studies by Validation, OTS and other support functions.

Education & Experience

• A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering • Manufacturing experience within a GMP regulated environment. • Experience of Buffer or Media preparation or Equipment preparation in a manufacturing environment. • Experience of the cell culture or purification processes in either a manufacturing or a lab based environment. • Experience of DCS (e.g. Delta V), SCADA and PLC systems • Experience of SAP, LIM’s and/or other business systems. • 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training.

If you would like further Information you can contact the recruiter directly: